Biosimilars

Regulation and uptake of ‘similar biologics’ in India

Biosimilars/Research | Posted 11/12/2015

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. But what are the drivers and the limitations to the ‘similar biologics’ market in India? This is a question Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India tried to address in his review of similar biologics in India [1].

Assessing the immunogenicity of monoclonal antibodies

Biosimilars/Research | Posted 04/12/2015

Safety is a major concern when it comes to biologicals (including biosimilars) and the most critical safety concern is immunogenicity. This is especially important in monoclonal antibody (mAb) biologicals, which are large molecules with complex structures and functions and which represent the largest class of biologicals [1].

Positive phase III results for adalimumab biosimilar

Biosimilars/Research | Posted 04/12/2015

US-based biologicals giant Amgen announced on 9 November 2015 that results from a phase III study of its adalimumab biosimilar (ABP 501) had ‘met the primary endpoint’.

FDA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 04/12/2015

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

Infliximab price wars

Biosimilars/News | Posted 04/12/2015

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.

Outcry at new US biosimilars reimbursement policy

Biosimilars/General | Posted 04/12/2015

A newly announced US Centers for Medicare and Medicaid Services (CMS) rule that gathers together all biosimilars of a single reference product under just one code has been widely criticized by drugmakers. Drugmakers warn that the rule on Medicare physician payment would reduce incentives for developing biosimilars, reduce patient access and create safety issues due to the inability to differentiate between biosimilars and reference products.

EMA recommends approval of etanercept biosimilar

Biosimilars/News | Posted 27/11/2015

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 November 2015 that it had recommended granting of marketing authorization for a biosimilar etanercept product (SB4).

Amgen submits biosimilar adalimumab application to FDA

Biosimilars/News | Posted 27/11/2015

Biotech giant Amgen announced on 25 November 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration (FDA).

AE reporting for biologicals

Biosimilars/Research | Posted 27/11/2015

Researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1] examined primary suspect reports sent to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) from US reporters for two biologicals that have lost patent exclusivity – somatropin and human insulin. The study was carried out to inform both FDA and the global drug development community about how naming of biosimilars might affect the traceability of adverse events (AEs).

Positive phase III results for etanercept biosimilar

Biosimilars/Research | Posted 27/11/2015

On 9 November 2015, biopharmaceutical specialists Coherus and Baxalta (a spin-off company from Baxter International) announced positive results from a phase III study of its etanercept biosimilar (CHS-0214).

Biosimilar naming in the US, the debate continues

Biosimilars/General | Posted 20/11/2015

The United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.

Biosimilar naming conventions around the world

Biosimilars/Research | Posted 20/11/2015

Naming conventions from around the world was one of the topics investigated in a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) [1].

Positive phase III results for Samsung Bioepis biosimilars

Biosimilars/Research | Posted 20/11/2015

Results of phase III clinical studies of candidate etanercept biosimilar SB4 infliximab biosimilar SB2 and adalimumab biosimilar SB5 have all met their primary endpoints, according to an announcement on 7 November 2015 by Samsung Bioepis (a Biogen and Samsung joint venture).

Celltrion submits rituximab biosimilar application to EMA

Biosimilars/News | Posted 20/11/2015

South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).

Biologicals patent expiries

Biosimilars/General | Posted 13/11/2015

Biosimilars are now a reality. The European Medicines Agency (EMA) approved its first biosimilar back in 2006 [1] and, with the increasing price of new biologicals and continuing pressure on healthcare budgets, biosimilars are expected to make up an increasing share of the biologicals market.

Biosimilars and interchangeability

Biosimilars/Research | Posted 13/11/2015

In a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) the question of interchangeability around the world was one of the topics investigated [1].

Economic considerations for rheumatoid arthritis biosimilars

Biosimilars/Research | Posted 13/11/2015

In the paper by Gulácsi et al. [1], the authors stated that biosimilars have the potential to reduce costs and increase patient access to biologicals in the treatment of rheumatoid arthritis (RA) and other chronic inflammatory rheumatic and bowel diseases.

Formycon starts phase III trial for ranibizumab biosimilar

Biosimilars/News | Posted 13/11/2015

German biosimilars companies Formycon and Bioeq announced on 7 October 2015 that they had initiated a pivotal phase III clinical trial with their candidate ranibizumab biosimilar (FYB201).

Non-originator low molecular weight heparins: generics or biosimilars

Biosimilars/Research | Posted 06/11/2015

First developed in the 1980s, low molecular weight heparins (LMWHs) are complex anticoagulants derived from porcine intestinal mucosa and are used in the treatment of deep vein thrombosis and pulmonary embolism. Heparin sodium’s anticoagulant activity is mainly governed by its ability to bind to the serine protease inhibitor antithrombin (AT). In this sense, heparin sodium functions as a cofactor for AT by modifying its conformation, thereby accelerating the inactivation of clotting factors.

Positive phase I results for adalimumab biosimilar

Biosimilars/Research | Posted 06/11/2015

In an announcement on 28 October 2015, biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) claimed that results from a phase I study of its adalimumab biosimilar (BI 695501) had ‘demonstrated pharmacokinetic bioequivalence’ to Humira (adalimumab).